Back to resultsSecond Window Indocyanine Green for All Nervous System Tumors
Primary Purpose
Nervous System Tumor
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Administration of Indocyanine Green (ICG) and Visualization of Tumor
Sponsored by
About this trial
This is an interventional other trial for Nervous System Tumor
Eligibility Criteria
Inclusion Criteria: Adult patients 18 years of age and older Patients presenting with a nervous system tumor presumed to be resectable and at risk for local recurrence on pre-operative assessment Good operative candidates, as determined by the treating physician and multidisciplinary team Subjects capable of giving informed consent Exclusion Criteria: Pregnant women, as determined by urinary or serum beta hCG within 48 hours of surgery Subjects with a history of iodide allergies Vulnerable patient populations Patients unable to participate in the consent process Patients with history of uncontrolled HTN (requiring ER admission or ≥ 3 BP medications)
Sites / Locations
- Pennsylvania HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SWIG Arm
Arm Description
This is the only arm for the study and will be experimental. All patients will receive the appropriate dosage of the study drug, which will then be used for visualization of the tumor intraoperatively.
Outcomes
Primary Outcome Measures
Tumor NIR Signal Compared to Background Brain Normal Signal (SBR)
SBR analysis will be stratified by histology, and the dosing and timing flowchart will be used to achieve optimal SBR.
NIR Efficiency
After examining the "equivocal tissue" with white light and NIR imaging, a per person success will be recorded, if least one additional specimen is resected using NIR. NIR will be considered efficacious, if significantly more than 10% of patients meet the success criteria. Each histology will be tested separately.
NIR True Positive Rate
Of the additionally resected specimens using NIR, we will find the true positive rate based on pathology. The entire sample will be evaluated jointly; then, each histology will be evaluated separately as there may be multiple specimens per patient surgery. NIR will be considered efficacious if the true positive rate is significantly greater than 50%.
Secondary Outcome Measures
Safety and Toxicity
Safety and toxicity will be evaluated by review of vital signs and any reported or observed adverse events (AEs).
Association Between Resection Decision and Pathology
Test for an association between a change in resection decision (yes/no) and the pathology results for all resected equivocal tissues will be completed. The association will be tested unadjusted and after controlling tumor location stratified by histology.
Sensitivity
The ROC curve will be analyzed, and the sensitivity, with its respective confidence intervals, will be estimated.
Specificity
The ROC curve will be analyzed, and the specificity, with their respective confidence intervals, will be estimated.
Positive Predictive Value
The ROC curve will be analyzed, and the positive predictive value, with their respective confidence intervals, will be estimated.
Negative Predictive Value
The ROC curve will be analyzed, and the negative predictive value, with their respective confidence intervals, will be estimated.
Full Information
NCT ID
NCT05746104
First Posted
February 17, 2023
Last Updated
June 27, 2023
Sponsor
Abramson Cancer Center at Penn Medicine
1. Study Identification
Unique Protocol Identification Number
NCT05746104
Brief Title
Second Window Indocyanine Green for All Nervous System Tumors
Official Title
Intraoperative Molecular Imaging of Central Nervous System Tumors Using Same Day Second Window Imaging With Indocyanine Green (TumorGlow™ - CNS)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 31, 2023 (Actual)
Primary Completion Date
February 15, 2025 (Anticipated)
Study Completion Date
February 15, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abramson Cancer Center at Penn Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study is being conducted to determine if a same-day, low-dose intravenous (into a vein) injection of indocyanine green (ICG) (FDA-approved dye) being detected by using an imaging system can be a useful tool in identifying and differentiating tumor tissue from normal tissues.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nervous System Tumor
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
105 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SWIG Arm
Arm Type
Experimental
Arm Description
This is the only arm for the study and will be experimental. All patients will receive the appropriate dosage of the study drug, which will then be used for visualization of the tumor intraoperatively.
Intervention Type
Drug
Intervention Name(s)
Administration of Indocyanine Green (ICG) and Visualization of Tumor
Intervention Description
A single dose of the study drug, ICG, of less than 2 mg/kg will be administered on the day of surgery. The visualization of second window ICG for tumor will be performed approximately one to four hours after administration, depending on how long it takes for the neurosurgeon to get through the skin/skull or lamina/dura to the tumor.
Primary Outcome Measure Information:
Title
Tumor NIR Signal Compared to Background Brain Normal Signal (SBR)
Description
SBR analysis will be stratified by histology, and the dosing and timing flowchart will be used to achieve optimal SBR.
Time Frame
Surgery
Title
NIR Efficiency
Description
After examining the "equivocal tissue" with white light and NIR imaging, a per person success will be recorded, if least one additional specimen is resected using NIR. NIR will be considered efficacious, if significantly more than 10% of patients meet the success criteria. Each histology will be tested separately.
Time Frame
Surgery
Title
NIR True Positive Rate
Description
Of the additionally resected specimens using NIR, we will find the true positive rate based on pathology. The entire sample will be evaluated jointly; then, each histology will be evaluated separately as there may be multiple specimens per patient surgery. NIR will be considered efficacious if the true positive rate is significantly greater than 50%.
Time Frame
Surgery
Secondary Outcome Measure Information:
Title
Safety and Toxicity
Description
Safety and toxicity will be evaluated by review of vital signs and any reported or observed adverse events (AEs).
Time Frame
Surgery
Title
Association Between Resection Decision and Pathology
Description
Test for an association between a change in resection decision (yes/no) and the pathology results for all resected equivocal tissues will be completed. The association will be tested unadjusted and after controlling tumor location stratified by histology.
Time Frame
Surgery
Title
Sensitivity
Description
The ROC curve will be analyzed, and the sensitivity, with its respective confidence intervals, will be estimated.
Time Frame
Surgery
Title
Specificity
Description
The ROC curve will be analyzed, and the specificity, with their respective confidence intervals, will be estimated.
Time Frame
Surgery
Title
Positive Predictive Value
Description
The ROC curve will be analyzed, and the positive predictive value, with their respective confidence intervals, will be estimated.
Time Frame
Surgery
Title
Negative Predictive Value
Description
The ROC curve will be analyzed, and the negative predictive value, with their respective confidence intervals, will be estimated.
Time Frame
Surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients 18 years of age and older
Patients presenting with a nervous system tumor presumed to be resectable and at risk for local recurrence on pre-operative assessment
Good operative candidates, as determined by the treating physician and multidisciplinary team
Subjects capable of giving informed consent
Exclusion Criteria:
Pregnant women, as determined by urinary or serum beta hCG within 48 hours of surgery
Subjects with a history of iodide allergies
Vulnerable patient populations
Patients unable to participate in the consent process
Patients with history of uncontrolled HTN (requiring ER admission or ≥ 3 BP medications)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marie Kerr, CCRP
Phone
215-829-6720
Email
marie.kerr@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica Nguyen, BS
Phone
215-829-6720
Email
jessica.nguyen@pennmedicine.upenn.edu
Facility Information:
Facility Name
Pennsylvania Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Y Lee, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Second Window Indocyanine Green for All Nervous System Tumors
We'll reach out to this number within 24 hrs